Patient-Reported Outcome Data

2019 ◽  
pp. 249-267
Author(s):  
Robert O. Morgan ◽  
Kavita R. Sail ◽  
Laura E. Witte
Keyword(s):  
Patient Reported Outcome ◽  
Outcome Data ◽  
Patient Reported

PatientConcept App � an innovative tool to improve therapy adherence and to implement risk management plans. (Preprint)

2018 ◽  
Author(s):  
Michael Lang ◽  
Martin Mayr ◽  
Stefan Ringbauer ◽  
Lukas Cepek
Keyword(s):  
Risk Management ◽  
Disease Management ◽  
Chronically Ill ◽  
Patient Reported Outcome ◽  
Outcome Data ◽  
Daily Routine ◽  
Software Application ◽  
Patient Reported ◽  
Management Plans ◽  
Chronically Ill Patients

UNSTRUCTURED Background: Adherence constitutes a great challenge for disease management, particularly when treating chronically ill patients facing an extensive, complex and long-term therapy. Earlier studies emphasize the relevance of adherence for improving therapy benefits. Besides the positive impact of increased patient support, the use of mobile health applications has gained importance in disease management. Objective: We aimed to develop a software application providing innovative features to simplify the contact between patients and treating physicians in order to overcome adherence barriers, to implement risk management plans and to collect patient reported outcome data. Methods: A novel software application ensuring data security was developed. Various innovative modules have been implemented, enabling bidirectional communication between treating physicians and patients, supporting therapy monitoring and management and allowing the collection of large sets of anonymous patient data. Results: The PatientConcept app is freely available for download and is tested since 2016, with more than 1800 generated patient IDs and 279 patients documenting health data according to risk management plans online in 2017. The impact on adherence issues is currently tested in larger patient populations. Conclusion: This innovative app provides a feasible and cost-optimized possibility to intensify and simplify the communication between patients and their treating physicians across indications, thus promising an exceptional benefit to both. It may not only support chronically ill patients in managing their daily life and improving adherence, but can also facilitate the implementation of risk management plans through automated monitoring, thus supporting physicians in their daily routine. Furthermore, patient reported outcome data can be collected. Importantly, a secure ID-associated data management ensures patient anonymity complying with highest data safety standards.

Health-related quality-of-life (HRQoL) analysis from a randomized phase II trial of androgen signaling inhibitors with or without androgen deprivation therapy (ADT) for castration-sensitive prostate cancer: LACOG 0415.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 64-64
Author(s):  
Andrey Soares ◽  
Diogo Assed Bastos ◽  
Fabio A. B. Schutz ◽  
Eduardo Cronemberger ◽  
Murilo Luz ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Locally Advanced ◽  
Patient Reported Outcome ◽  
Abiraterone Acetate ◽  
Outcome Data ◽  
Rank Test ◽  
Emotional Wellbeing ◽  
Patient Reported ◽  
Related Quality

64 Background: LACOG0415 is a 3-arm randomized trial evaluating ADT with abiraterone acetate plus prednisone (ADT+AAP), apalutamide alone (APA) or apalutamide with AAP (APA+AAP) for patients with locally-advanced, high-risk biochemical recurrence or metastatic castration-sensitive prostate cancer (ASCO 2020). In this trial, ADT+AAP and APA+AAP achieved the primary endpoint of percentage of patients with PSA ≤ 0.2 ng/mL at week 25. Apalutamide alone showed a high PSA decline > 50% rate, but did not achieve the pre-specified PSA threshold. Here we report patient-reported outcome data using Functional Assessment of Cancer Therapy-Prostate (FACT-P). Methods: HRQoL was measured in the overall population using the FACT-P questionnaire, comprising 5 subscales: physical wellbeing (PWB), functional wellbeing (FWB), emotional wellbeing (EWB), social/family wellbeing (SFWB), and prostate cancer subscale (PCS). Scores for each patient were measured at baseline and every four weeks until week 25. Questionnaire completion was defined as ≥ 1 question answered at an assessment time point. Analysis of HRQoL change from baseline and deterioration included only patients with baseline and ≥ 1 postbaseline score. Differences greater than 10-points in FACT-P total score and differences greater than 3-points in PWB, FWB, EWB, SFWB, and PCS scores were considered clinically significant. The time-to-event endpoint was estimated by Kaplan-Meier method and compared by stratified log-rank test. Results: 128 patients were included in LACOG0415 trial and 122 of them completed the HRQoL assessments (ranging from 95.3% at baseline to 79.7% at week 25). FACT-P and all subscales scores were similar for all three arms at baseline. There were no meaningful differences in FACT-P scores at baseline and at week 25 between the 3 arms. The subscales scores also showed no statistically differences at baseline and at week 25. Time to FACT-P deterioration did not show any statistically difference between three arms ( P=0.3371). Conclusions: ADT free alternatives with APA alone or APA+AAP did not show meaningful differences in HRQoL in patients with advanced castration-sensitive prostate cancer compared to ADT+AAP. The short follow-up period limited the ability to explore differences in HRQoL after 25 weeks. Larger studies with longer follow-up are needed to further evaluate HRQoL with ADT-free strategies. Clinical trial information: NCT02867020. [Table: see text]

Analyzing patient‐reported outcome data when completion differs between arms in open‐label trials: an application of principal stratification

2019 ◽  
Vol 28 (10) ◽  
pp. 1386-1394 ◽  
Author(s):  
Jessica K. Roydhouse ◽  
Roee Gutman ◽  
Vishal Bhatnagar ◽  
Paul G. Kluetz ◽  
Rajeshwari Sridhara ◽  
...  
Keyword(s):  
Patient Reported Outcome ◽  
Outcome Data ◽  
Principal Stratification ◽  
Open Label ◽  
Patient Reported

Implant-based Mesh Supported Breast Reconstruction: Patient Reported Outcome Data (PRO-BRA trial, TiLOOP® Bra) and Perspectives

2018 ◽  
Vol 92 ◽  
pp. S87 ◽  
Author(s):  
S. Paepke ◽  
E. Klein ◽  
M. Kiechle ◽  
C. Ankel ◽  
A. Faridi ◽  
...  
Keyword(s):  
Breast Reconstruction ◽  
Patient Reported Outcome ◽  
Outcome Data ◽  
Patient Reported

Using generalized estimating equations and extensions in randomized trials with missing longitudinal patient reported outcome data

2018 ◽  
Vol 27 (9) ◽  
pp. 2125-2131 ◽  
Author(s):  
Melanie L. Bell ◽  
Nicholas J. Horton ◽  
Haryana M. Dhillon ◽  
Victoria J. Bray ◽  
Janette Vardy
Keyword(s):  
Generalized Estimating Equations ◽  
Randomized Trials ◽  
Estimating Equations ◽  
Patient Reported Outcome ◽  
Outcome Data ◽  
Patient Reported ◽  
Generalized Estimating

scholarly journals Obtaining Patient Reported Outcome Data in the Era of Electronic Medical Records

2018 ◽  
Vol 24 (3) ◽  
pp. S267-S268
Author(s):  
Lauren E. Brister ◽  
Leland Metheny ◽  
Linda K. Baer ◽  
Molly Gallogly
Keyword(s):  
Electronic Medical Records ◽  
Medical Records ◽  
Patient Reported Outcome ◽  
Outcome Data ◽  
Patient Reported

scholarly journals Does pain and hip function improve 2 years after reverse periacetabular osteotomy? A follow-up study of 74 patients

2020 ◽  
Vol 7 (1) ◽  
pp. 130-139 ◽  
Author(s):  
Christina Nielsen Bræmer ◽  
Sarah Ankjær Langberg ◽  
Stig Storgaard Jakobsen ◽  
Søren Reinhold Jakobsen ◽  
Hugo Aleixo ◽  
...  
Keyword(s):  
Short Form ◽  
Periacetabular Osteotomy ◽  
Patient Reported Outcome ◽  
Outcome Data ◽  
University Hospital ◽  
Follow Up Study ◽  
Background Population ◽  
Patient Reported ◽  
Hip Function

Abstract Data on outcome in patients with acetabular retroversion (AR) treated with reverse periacetabular osteotomy (reverse PAO) are sparse. The aim of the study was to investigate changes in pain and hip function among patients with AR 2 years after reverse PAO and to examine whether changes in pain were associated with changes in hip function. In addition, to evaluate patient satisfaction and changes in quality of life (QoL). We present a prospective follow-up study with patient-reported outcome data from Aarhus University Hospital in Denmark. Pain at rest and during activity was measured with a Visual Analogue Scale (VAS), hip function with the Hip disability and Osteoarthritis Outcome Score (HOOS) and QoL with the Short-Form 36, pre-operatively and 2 years after reverse PAO in 74 patients. Changes were analysed using paired t-test and multiple linear regressions. Significant and clinically relevant mean improvements in pain and hip function were found. The numbers of responders achieving a minimal clinically important difference varied from 51 to 73%. Positive significant association between changes in pain and changes in hip function were found. Significant mean improvement in QoL was found. The study had a loss to follow-up of 23%. Two years after reverse PAO, patients diagnosed with AR showed significant and clinically relevant mean improvements in pain and hip function. Decreased pain was significantly associated with improved hip function. The majority of patients were satisfied with the result of surgery and QoL was similar to the Danish background population.

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